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Articles by Patrick Middag
12.22.22 -- FDA Accepts Biogen BLA For Biosimilar Actemra
By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
12.21.22 -- New Year For Novo Nordisk's Wegovy Supply Challenges
By Patrick Middag and Dennie van de Voort, Deloitte Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how the data will be governed.
12.16.22 -- 5 Steps To Eliminate Weak Links In Your Data Governance
Article | By William C. Barrett, Ph.D., and Doug Puzia, W.L. Gore & Associates It’s time to look at how new protein A technologies may replace resin-based methods and enable more productive and flexible purification. Webinar | ILC Dover Learn about best-in-class solutions to streamline the transfer process, resulting in more accurate and faster production and improved batch cycle times.
Embedding effective data governance practices across pharma
Deloitte’s Patrick Middag and Dennie van de Voort provide some practical steps to creating and entrenching effective data governance practices which in turn can help elevate the quality and value of regulated pharma data – not just for the immediate use case, but also for other critical applications beyond the regulatory function. Key insights: Maintaining data quality and consistency holds the key to critical pharma production and regulatory processes.
12.08.22 -- 5 Steps To Eliminate Weak Links In Data Governance
By Patrick Middag and Dennie van de Voort, Deloitte Major regulators, including the FDA and EMA, have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how those data will be governed.
5 Steps To Eliminate Weak Links In Your Data Governance Original
By Patrick Middag and Dennie van de Voort, Deloitte The future of life sciences efficiency and innovation, in bringing important products to market, relies on a dependable flow of agreed data, and major regulators including the European Medicines Agency and FDA have established frameworks through which this must be captured and exchanged with them. But companies need a solid plan for how that data will be governed.
5 Steps To Eliminate Weak Links In Your Data Governance
By Patrick Middag and Dennie van de Voort, Deloitte The future of life sciences efficiency and innovation, in bringing important products to market, relies on a dependable flow of agreed data, and major regulators including the European Medicines Agency and FDA have established frameworks through which this must be captured and exchanged with them. But companies need a solid plan for how that data will be governed.
5 Steps To Eliminate Weak Links In Your Data Governance
By Patrick Middag and Dennie van de Voort, Deloitte The future of life sciences efficiency and innovation, in bringing important products to market, relies on a dependable flow of agreed data, and major regulators including the European Medicines Agency and FDA have established frameworks through which this must be captured and exchanged with them. But companies need a solid plan for how that data will be governed.
5 Steps To Eliminate Weak Links In Your Data Governance
By Patrick Middag and Dennie van de Voort, Deloitte The future of life sciences efficiency and innovation, in bringing important products to market, relies on a dependable flow of agreed data, and major regulators including the European Medicines Agency and FDA have established frameworks through which this must be captured and exchanged with them. But companies need a solid plan for how that data will be governed.
5 Steps To Eliminate Weak Links In Your Data Governance
By Patrick Middag and Dennie van de Voort, Deloitte The future of life sciences efficiency and innovation, in bringing important products to market, relies on a dependable flow of agreed data, and major regulators including the European Medicines Agency and FDA have established frameworks through which this must be captured and exchanged with them. But companies need a solid plan for how that data will be governed.
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